Proposed Rule

FDA Requiring Manufacturers to Show OTC Antibacterial Products Are Safe, Effective

December 17, 2013 06:06 pm News Staff

With more than 2,000 hand soap and body wash products on the U.S. market that contain at least one so-called antibacterial ingredient, a newly proposed rule from the FDA( that focuses on the safety and efficacy of such products could have far-reaching effects on consumers and health care professionals alike.

[Stock photo of woman washing hands with soap]

"Millions of Americans use antibacterial hand soaps and body washes," said Sandra Kweder, M.D., deputy director in the Office of New Drugs in the Center for Drug Evaluation and Research, in a Dec. 16 telebriefing. "They're used every day at home, at work, in schools and in other public settings, like child care centers, where the risk of bacterial infection is actually relatively low."

That ongoing high level of consumer exposure, coupled with a growing body of research suggesting that the active ingredients used in these products are not without risk, has prompted the FDA to issue a proposed rule( that would require manufacturers of these OTC products to submit research demonstrating they are what the agency terms "generally recognized as safe and effective" (GRAS/GRAE) to be able to continue marketing them as currently formulated and labeled.

Story Highlights
  • Millions of Americans use antibacterial hand soaps and body washes on a daily basis, despite no solid evidence that they are safe or effective in preventing infection.
  • The FDA has issued a proposed rule that would require manufacturers of these OTC products to submit research showing they are "generally recognized as safe and effective."
  • After the rule is finalized, manufacturers will have one year to comply or they will be required to reformulate or relabel their products.

It's important to note that the proposed rule pertains only to hand soaps and body washes marketed as containing antibacterial ingredients; hand sanitizers, antiseptic wipes and antibacterial products used in health care settings are not affected by the proposal, Kweder said.

New Data Requirements Outlined

According to the proposed rule, the agency seeks to establish new conditions under which such OTC antiseptic products would be considered GRAS/GRAE based on an ongoing re-evaluation of safety and effectiveness data requirements first proposed in a 1994 tentative final monograph (TFM). The FDA issued the TFM as part of its rulemaking regarding OTC drug products marketed in the United States.

That 1994 TFM classified 22 active ingredients for OTC antiseptic handwash use, only one of which -- povidone-iodine -- was proposed to be classified as GRAS/GRAE at that time. The FDA's current action, however, would require submission of safety and efficacy data for all 22 ingredients, including povidone-iodine. Of particular interest are triclosan, which is commonly used in liquid soaps, and triclocarban, a common ingredient in bar soaps.

Comments received during the course of the FDA re-evaluation to date, as well as input from public meetings and the agency's assessment of other relevant scientific information, have failed to provide "sufficient data to show that there is any additional benefit from the use of consumer antiseptic hand or body washes compared to nonantibacterial soap and water," said the FDA in the proposed rule.

Moreover, a number of important developments that affect how the safety of these ingredients is evaluated have occurred since the FDA released the 1994 TFM. "New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available," the agency noted in its proposal.

Among those risks are concerns about possible hormonal and other toxicities associated with these products based on "alterations in thyroid, reproductive, growth and developmental systems of neonatal and adolescent animals." Another concern is whether antimicrobial resistance could develop following their long-term, repeated use.

"To put it simply, we need to collect additional information from the companies that make and market these products so that consumers can be confident about their effectiveness and about their safety," Kweder said during the briefing.

Agency Seeks Stakeholder Comments

The FDA has opened a 180-day comment period on the proposed rule and invites clinicians, consumers and other stakeholders to share their thoughts about the proposal. Comments may be submitted online via the Federal eRulemaking Portal( at or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

After the rule is finalized, manufacturers will have one year to comply with the data submission requirements. At that time, manufacturers who are not able to demonstrate the safety and efficacy of the OTC antibacterial products they market will be required to reformulate them without those ingredients or relabel them to remove the antibacterial claim.

The FDA estimates the one-time cost to reformulate/relabel existing products would range from $112.2 million to $368.8 million.

Any products that retained the ingredients now under scrutiny would still be required to list those ingredients on the product label, said Kweder. "They would still have to state that the ingredients are there, and we think that's an important caveat because consumers would know if they were using these ingredients at all."

According to Kweder, the agency would consider requiring the removal of these ingredients should they be found to not meet GRAS/GRAE criteria. "That's absolutely on the table," she said during the telebriefing.

"We haven't done that in a long time; we did do it in the 1970s. Some of you who were around then may remember hexachlorophene. We actually required that that be removed from the market because we found that it had effects on the brains of young children."

It all comes down to the evidence, said Kweder. "What has been well established is that hand washing with soap and water does decrease the transmission of infections ... what has not been shown is that when you add these antibacterial ingredients to the soap, while you may get a little bit of extra decrease of bacterial counts on the surface of the skin, whether that really makes any difference -- in your home or your daycare center or your school classroom -- in how often people get sick.

"We think that consumers deserve to know that."